曲克芦丁注射剂临床不良反应分析及对策

Analysis of clinical adverse reactions and countermeasures of Troxerutin injection

目的通过文献分析探索曲克芦丁注射剂临床发生不良反应的规律,并从临床使用、生产工艺及质量控制等方向寻求安全对策,旨在为该药物注射剂型的用药安全提供建议。方法检索中国知网、万方、维普等数据库2015年1月至2021年12月曲克芦丁注射剂不良反应相关文献报告,共纳入97例曲克芦丁注射剂不良反应病例作统计汇总,所得相关信息为临床使用提供指导建议或关注点。同时检索文献,从使用、工艺及质控等角度汇报提高该注射剂型质量和使用安全的研究进展及应对情况。结果临床不良反应97例患者中,51~80岁的中老年人占全部病例的75.26%,不良反应多出现在用药30 min内;变态反应占36.08%,其主要表现为一般类型过敏反应。临床配药需注意配伍规范使用,药物原料合成及制剂生产工艺需注意控制引入的有风险杂质。结论临床选用曲克芦丁注射剂时,应充分明确用法用量及配伍禁忌,加强前30 min监护,提高对不良反应尤其是变态反应的应急救治能力;生产企业应密切关注临床不良反应监测分析,加强生产及质控、标准和检验方法研究,推动曲克芦丁注射剂的质量安全性再评价,完善说明书,提升药品质量。

Objective To explore the regularity of clinical adverse reactions of Troxerutin injection through literature analysis,and the safety countermeasures were sought from the aspects of clinical use,production process and quality control,so as to provide suggestions for the safety of the drug injection.Methods A total of 97 adverse drug reactions cases of Troxerutin injection were collected from January 2015 to December 2021 by searching the related literature reports in CNKI,WANFANG,VIP-CSTJ and other databases,the relevant information obtained provide guidance and suggestions for clinical use.And the research progress and countermeasures to improve the quality and safety of the injection were reported from the perspectives of use,process and quality control through the literature.Results Among the 97 cases with clinical adverse reactions,75.26%of all cases were between the ages of 51 and 80,and most of the adverse reactions occurred within 30 min of medication.Allergic reaction accounted for 36.08%,which was mainly manifested as general type allergic reaction.Attention should be paid to the standard use of compatibility in clinical dispensing,also should pay attention to control the introduction of risky impurities on the synthesis of pharmaceutical raw materials and the production process of preparations.Conclusion When Troxerutin injection is clinically selected,the dosage and incompatibilities should be fully clarified,and the first 30 min of monitoring should be strengthened to improve the emergency treatment ability for adverse reactions,especially allergic reactions.Pharmaceutical factory should pay close attention to the monitoring and analysis of clinical adverse reactions,strengthen the research on production and quality control,standards and test methods,promote the re-evaluation of the quality and safety of Troxerutin injection,improve the instructions and the drug quality.